Senior Manager Regulatory Affairs
Posted Updated
Description
This role is also responsible for leading the preparation and submission of product Technical Files, Standard Technical Documentation, and other related documents for market authorizations in Japan. The Director will drive the development and implementation of regulatory strategies for assigned projects, covering new product introductions, product modifications, and manufacturing improvements in Japan. Additionally, the role involves creating and enforcing local regulatory procedures and educating others on Japanese regulatory standards. The Director will collaborate with the Japanese leadership team and other international functions to ensure product registration and compliance in Japan.
Requirements
- Bachelor’s degree in Physical or Life Sciences, or a High School Diploma/GED with 4 years of relevant experience in place of a degree.
- Over 10 years of experience in the regulatory field.
- At least 8 years of regulatory affairs experience within the IVD/Medical Device industry, including 2 years of management experience with employee leadership and development.
Benefits
- Competitive salary, equity compensation, discretionary bonuses, and recognition programs.
- Health, wellness, and leave benefits, including medical, prescription, dental coverage, and time off for holidays, vacation, sick leave, and other leaves
- Ensured career growth with a like-minded international team